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Comparison Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hernia repair
Sponsored by
Uşak University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • inguinal hernia

Exclusion Criteria:

  • recurrent hernia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    lichtenstein

    Arm Description

    hernia repair

    Outcomes

    Primary Outcome Measures

    recurrence
    hernia recurrence

    Secondary Outcome Measures

    Full Information

    First Posted
    October 23, 2018
    Last Updated
    January 27, 2019
    Sponsor
    Uşak University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03820570
    Brief Title
    Comparison Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy
    Official Title
    Comparison of Early and Long Term Outcomes of Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy for Primary Inguinal Hernias
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2012 (Actual)
    Primary Completion Date
    January 1, 2015 (Actual)
    Study Completion Date
    December 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Uşak University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    comparison of early and long term results of open lichtenstein repair and totally extraperitoneal herniorrhaphy for primary inguinal hernias.
    Detailed Description
    Early results such as postoperative pain, operation time and long term results such as chronic pain and recurrence will be compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    lichtenstein
    Arm Type
    Experimental
    Arm Description
    hernia repair
    Intervention Type
    Procedure
    Intervention Name(s)
    hernia repair
    Intervention Description
    inguinal hernia repair
    Primary Outcome Measure Information:
    Title
    recurrence
    Description
    hernia recurrence
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: inguinal hernia Exclusion Criteria: recurrent hernia

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy

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